Abstract 12225: First-in-man Experience With Intracoronary Infusion of Adipose-Derived Regenerative Cells in the Treatment of Patients with ST-Elevation Myocardial Infarction: The Apollo Trial
Background: Autologous adipose-derived regenerative cells (ADRCs) can be readily obtained from subcutaneous adipose tissue in sufficient amount for therapy. The abundance of adipose tissue in patients and the higher frequency of adult stem cells per unit mass allows for fast isolation of cells in less than two hours. This allows for treatment during the same procedure as the harvest of the adipose tissue and can thus be appended to a primary PCI of an AMI.
Methods: APOLLO is a prospective, double-blind, randomized, placebo-controlled first-in-man cell therapy study that enrolled 14 patients to determine the safety and feasibility of ADRCs delivered via the intracoronary route in the treatment of patients with a STEMI. Following standard liposuction and cell isolation, patients were randomly assigned 3:1 to receive intracoronary infusion of 20x106 ADRC or placebo within 24 hrs after the primary PCI.
Results: At 6 months, SPECT imaging demonstrated a marked improvement in myocardial perfusion defect and an improvement of LVEF of 5,7% in the ADRC-treated group compared to placebo patients. In addition, ADRC therapy resulted in a marked reduction of infarct size as quantified by late enhancement MRI (expressed as infarct mass relative to total LV mass). Mean infarct size was reduced from 31.6% at baseline, to 15.4% at 6 month FU in ADRC treated patients, whereas placebo treated patients had an infarct size of 24.7%, both at baseline and at 6 month FU. The liposuction procedure and intracoronary infusion of ADRCs in these AMI patients were well tolerated. The only adverse effect experienced was hematoma formation in 2 patients; one was receiving dual antiplatelet therapy, glycoprotein inhibitor and heparin, and the other had a greatly prolonged aPTT.
Conclusions: The APOLLO study is the first-in-man experience of adipose-derived regenerative cell therapy in patients with a STEMI. This study suggests that these cells can be safely obtained and administered via intracoronary infusion to patients post AMI. Furthermore, the clinically significant reduction in infarct size, increase in myocardial perfusion and ejection fraction seen in this study, while not statistically significant, are concordant and consistent with our understanding of mechanisms of action for ADRCs.
- © 2010 by American Heart Association, Inc.